Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1818-2019 | 06-12-2019 | VINCRISTINE 1 MG /50 ML NS IVPB; VINCRISTINE 1.2 MG /50 ML NACL 0.9% IVPB; VINCRISTINE 1 MG / 1 ML IVP SYRINGE; VINCRISTINE 2 MG /100 ML D5W IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1794-2019 | 06-12-2019 | ONDANSETRON 8 MG / 50 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1754-2019 | 06-12-2019 | BORTEZOMIB 2.5 mg / 1 ML SQ SYRINGE; BORTEZOMIB 2.88 MG / 1.15 ML SQ SYRINGE; BORTEZOMIB 2.31 MG / 0.92 ml SQ SYRINGE; BORTEZOMIB 2.7 mg / 1.08 ML SQ SYRINGE; BORTEZOMIB 1.45 mg / 0.58 ml SQ SYRINGE; BORTEZOMIB 2.25 mg (0.9 ML) SQ SYRINGE; BORTEZOMIB 1.98 mg / 0.79 ml SQ SYRINGE, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1816-2019 | 06-12-2019 | VELCADE 2.1 mg / 0.84 ml SQ SYRINGE; VELCADE 2.5 MG/ 1 ML SUB-Q SYRINGE; VELCADE 2.2 MG/ 0.88 ML SUB-Q SYRINGE; VELCADE 2.6 MG (1.04 ML) Sub Q SYRINGE; VELCADE 4 mg / 1.6 ml SQ SYRINGE; VELCADE 2.75 mg / 1.1 ml SQ SYRINGE; VELCADE 2.6 mg / 1.04 ml SQ SYRINGE VELCADE 1.7 mg / 0.68 ml SQ SYRINGE; VELCADE 3.5 mg / 1.4 ML SQ SYRINGE; VELCADE 2.2 mg / 0.88 ml SQ SYRINGE; VELCADE 2.33 MG/ 0.93 ML SUB-Q SYRINGE; VELCADE 2.4 MG/ 0.96 ML SUB-Q SYRINGE VELCADE 2.63 MG/ 1.052 ML SUB-Q SYRINGE, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1804-2019 | 06-12-2019 | PERJETA 420 MG/250 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1749-2019 | 06-12-2019 | ATEZOLIZUMAB 1200 MG / 250 ML 0.9% NACL, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1774-2019 | 06-12-2019 | ERBITUX 770 MG/ 385 ML IVPB; ERBITUX 440 MG/ 220 ml IVPB; ERBITUX 850 MG/ 425 ml IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1755-2019 | 06-12-2019 | CALCIUM GLUCONATE 1 GM /100 ML NACL 0.9% IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1815-2019 | 06-12-2019 | TRASTUZUMAB 427 MG / 250 ml NS IVPB; TRASTUZUMAB 531 MG / 250 ML NS IVPB; TRASTUZUMAB 276 MG / 250 ML NS IVPB; TRASTUZUMAB 360 MG / 250 ML NS IVPB; TRASTUZUMAB 757 MG / 250 ML NS IVPB TRASTUZUMAB 450 MG / 250 ML NS IVPB; TRASTUZUMAB 120 MG / 250 ML NS IVPB; TRASTUZUMAB 164 MG / 250 ML NS IVPB; TRASTUZUMAB 444 MG / 250 ml NS IVPB; TRASTUZUMAB 634 MG / 250 ML NS IVPB; TRASTUZUMAB 330 MG / 250 ML NS IVPB; TRASTUZUMAB 781 MG / 250 ML NS IVPB; TRASTUZUMAB 376 mg / 250 ML NS IVPB; TRASTUZUMAB 114 MG / 250 ML NS IVPB; TRASTUZUMAB 266 MG / 250 ML NS IVPB TRASTUZUMAB 323 MG / 250 ML NS IVPB; Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1779-2019 | 06-12-2019 | Fluorouracil 560 MG / 11.2 ML IVP Fluorouracil 3340 MG QS 92 ML 0.9% NACL Fluorouracil 3920 MG QS 92 ML 0.9% NACL Fluorouracil 3760 mg QS 100 ml NS CASS Fluorouracil 4000 MG QS 92 ml 0.9% NACL Fluorouracil 3140 MG QS 240 ML NS PUMP Fluorouracil 2400 MG QS 96 ML 0.9% NACL Fluorouracil 5000 MG QS 101 ml 0.9% NACL Fluorouracil 750 MG / 15 ML IVP Fluorouracil 4500 mg QS 100 ml NS CASS Fluorouracil 4100 mg QS 100 ml NS CASS Fluorouracil 690 mg / 13.8 ml IVP Fluorouracil 2400 MG QS 96 ML NS IV Fluorouracil 812 MG/16.24 ML IVP Fluorouracil 4872 MG QS 240 ML NS PUMP Fluorouracil 4200 mg QS 100 ml NS CASS Fluorouracil 1110 MG QS 96 ml NS IVPB Fluorouracil 370 MG/ 50 ML NS Fluorouracil 620 MG/ 12.4 ML SYRINGE IVP Fluorouracil 3160 MG QS 92 ML 0.9% NACL Fluorouracil 1050 mg QS 92 ml NS IVPB Fluorouracil 370 MG /100 ML NS IVPB Fluorouracil 4080 MG QS 1000 ML NS IVPB Fluorouracil 5 MG / 0.1 ML SYRINGE Fluorouracil 5040 MG QS 101 ml NS CADD Fluorouracil 4224 MG QS 100 ml NS CASS Fluorouracil 700 MG / 14 ML IVP Fluorouracil 3550 mg QS 92 ML 0.9% NACL IV Fluorouracil 760 MG / 15.2 ML IVP Fluorouracil 4560 MG QS 240 ML NS PUMP Fluorouracil 796 MG / 15.92 MLIVP Fluorouracil 4776 MG QS 240 ML NS PUMP Fluorouracil 930 MG QS 240 ML NS PUMP Fluorouracil 730 MG / 14.6 ML IVP SYR Fluorouracil 4400 MG QS 100 ml NS CADD Fluorouracil 2430 MG QS 96 ml 0.9% NACL Fluorouracil 4728 MG QS 100 ml NS CASS Fluorouracil 3550 MG QS 92 ML 0.9% NACL Fluorouracil 588 MG / 11.76 ML IVP Fluorouracil 3528 MG QS 240 ML NS PUMP Fluorouracil 2520 mg QS 96 ml NS IVPB Fluorouracil 790 MG / 15.8 ml IVP Fluorouracil 4750 mg QS 97 ml 0.9% NACL IV Fluorouracil 2660 MG QS 96 ml NS IVPB Fluorouracil 720 MG/ 14.4 ML IVP Fluorouracil 4370 mg QS 92 ml 0.9% NACL IV Fluorouracil 3280 MG QS 92 ML 0.9% NACL Fluorouracil 780 MG / 15.6 ML IVP Fluorouracil 4660 MG QS 97 ml 0.9% NACL Fluorouracil 3620 MG QS 100 ml NS CASS Fluorouracil 2370 MG QS 92 ML 0.9% NACL Fluorouracil 800 MG / 16 ML IVP Fluorouracil 4800 MG QS 101 ml NS CADD Fluorouracil 4000 mg QS 92 ML 0.9% NACL IV Fluorouracil 2480 MG QS 96 ML 0.9% NACL Fluorouracil 688 MG / 13.76 ml IVP Fluorouracil 4128 MG QS 1000 ML D5W IVPB Fluorouracil 6000 MG QS 250 ml NS CASS Fluorouracil 672 MG / 13.44 ML IVP Fluorouracil 4032 MG / 1000 ML D5W IVPB Fluorouracil 894 MG / 17.88 ml IVP Fluorouracil 400 MG / 50 ML NS IVPB Fluorouracil 840 MG / 16.8 ml IVP Fluorouracil 590 MG/ 11.8 ML IVP | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1790-2019 | 06-12-2019 | METHOTREXATE 25 MG / 1 ML IM SYR; METHOTREXATE 12 mg QS 5 ml PF 0.9% NACL; METHOTREXATE 98 MG / 3.92 ML IM SYR; METHOTREXATE 55 MG / 2.2 ML IVP; METHOTREXATE 59.5 MG / 2.38 ML IVP; METHOTREXATE 12 mg QS 6 ml 0.9% NACL; METHOTREXATE 150 MG / 50 ML NS IVPB; METHOTREXATE 112.5 MG/ 4.5 ML IM SYR, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1785-2019 | 06-12-2019 | InFLIXimab 300 mg / 250 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1782-2019 | 06-12-2019 | GRANISETRON 1000 MCG / 50 ML NS, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1746-2019 | 06-12-2019 | Adcetris 96 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1760-2019 | 06-12-2019 | Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G; Cisplatin 80 MG / 250 ml 0.9% NACL; Cisplatin 44 MG QS 500 ml NS IVPB; Cisplatin 40 MG / 500 ml 0.9% NACL; Cisplatin 36 MG / 500 ML NS IVPB; Cisplatin 73 MG QS 500 ml 0.9% NACL WITH Mannitol 12.5 G; Cisplatin 70 MG / 500 ml NS WITH Magnesium 1 G and Mannitol 12.5 G; Cisplatin 60 MG /250 ml 0.9% NACL Cisplatin 47 MG /250 ml 0.9% NACL WITH Mannitol 12.5 G; Cisplatin 150 MG / 250 ml 0.9% NACL; Cisplatin 115 MG /250 ml NS IVPB; Cisplatin 80 MG QS 500 ml NS IVPB WITH Mannitol 12.5 G; Cisplatin 120 MG / 500 ML NS IVPB Cisplatin 157 MG /250 ml 0.9% NACL WITH Mannitol 12.5 G; Cisplatin 43 MG QS 1000 ml 0.9% NACL WITH Mannitol 12.5 G, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1809-2019 | 06-12-2019 | RITUXAN 728 MG QS 728 mL 0.9% NACL IVPB; RITUXAN 560 MG / 306 ml 0.9% NACL; RITUXAN 562 MG IN 562 ml 0.9% NACL; RITUXAN 700 MG QS 700 mL 0.9% NACL IVPB; RITUXAN 1000 MG / 350 mL 0.9% NACL IVPB RITUXAN 730 MG / 730 mL 0.9% NACL IVPB; RITUXAN 1000 MG QS 1000 ml NS; RITUXAN 1000 MG QS 200 ml 0.9% NACL; RITUXAN 500 MG / 300 ml 0.9% NACL; RITUXAN 660 MG QS 660 ml 0.9% NACL; RITUXAN 770 MG QS 770 mL 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1784-2019 | 06-12-2019 | IFOSFAMIDE 9200 MG / 1 L NS IVPB WITH MESNA 9200 MG, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1757-2019 | 06-12-2019 | CARFILZOMIB 65 MG IN 50 ML D5W IVPB; CARFILZOMIB 75 MG IN 50 ML D5W IVPB; CARFILZOMIB 50 MG IN 50 ML D5W IVPB; CARFILZOMIB 45 MG IN 50 ML D5W IVPB; CARFILZOMIB 46.2 MG IN 50 ML D5W IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1781-2019 | 06-12-2019 | Gemcitabine 1910 MG / 250 ML NS IVPB; Gemcitabine 1140 MG / 250 ML NS 0.9% IVPB; Gemcitabine 1290 MG /250 ML NS IVPB; Gemcitabine 460 MG / 250 ML NS IVPB; Gemcitabine 880 MG / 250 ML NS IVPB; Gemcitabine 810 MG / 250 ML NS IVPB; Gemcitabine 820 MG / 250 ML NS IVPB; Gemcitabine 1748 MG / 250 ML NS IVPB; Gemcitabine 890 MG /250 ML NS IVPB Gemcitabine 2000 MG /250 ML 0.9% NACL IVPB; Gemcitabine 660 MG / 250 ML NS IVPB; Gemcitabine 1880 MG /250 ML NS IVPB; Gemcitabine 1180 MG / 250 ML NS IVPB; Gemcitabine 1400 MG / 250 ML NS IVPB Gemcitabine 1300 MG / 250 ML NS IVPB; Gemcitabine 1406 MG /250 ML NS IVPB; Gemcitabine 1672 MG / 250 ML NS IVPB; Gemcitabine 2050 MG / 250 ML NS IVPB; Gemcitabine 1260 MG / 250 ML NS IVPB; Gemcitabine 1710 MG / 250 ML NS IVPB; Gemcitabine 1320 MG / 250 ML NS IVPB; Gemcitabine 1200 MG /250 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / N/A | Class II | Terminated |
| D-1744-2019 | 06-12-2019 | Oxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 | Lack of Assurance of Sterility | Infusion Options, Inc. / 820 60 units/bag | Class II | Terminated |
| D-1410-2019 | 06-10-2019 | Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr, USP 10mg,/Guaifenesin, USP 100mg, 118mL (4oz) bottle, Manufactured for Preferred Pharmaceuticals, Inc., Anaheim, CA 92807 by Major Pharmaceuticals, Livonia, MI 48152, NDC 68788-0841-01 | CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Preferred Pharmaceuticals, Inc / 192 4 oz bottles | Class II | Terminated |
| D-1488-2019 | 06-07-2019 | Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N Davis Ave Cleveland, MS 38732, 800-523-7749, NDC 61553-352-78 | Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite | PharMEDium Services, LLC / 28,140 syringes | Class I | Terminated |
| D-1392-2019 | 06-07-2019 | Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules containing 3 x 10 Prescription Packs, Rx Only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forest, IL 60045, NDC 61748-304-13 | Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly. | Akorn Inc / 16,216 cartons | Class III | Terminated |
| D-1455-2019 | 06-06-2019 | LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. | Teva Pharmaceuticals USA / 2,924,000 tablets | Class II | Ongoing |
| D-1456-2019 | 06-06-2019 | LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. | Teva Pharmaceuticals USA / 2,943,000 tablets | Class II | Ongoing |
| D-1390-2019 | 06-05-2019 | Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Release Tablets, USP, Allergy & Congestion, 20-count box.Distributed by: Walgreen Co. 200 Wilmore Rd. Deerfield, IL 40015. Made in India UPC 3 11917 19453 0 | Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit | Sun Pharmaceutical Industries, Inc. / 17,904 20-count units | Class II | Terminated |
| D-1409-2019 | 06-05-2019 | Cetirizine Oral Solution 1 mg/mL, Up & Up, Children's allergy relief, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. (118 mL) Bottle, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-178-04, UPC 359726178044. | cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | P & L Developments, LLC / 124,512 bottles | Class II | Terminated |
| D-1388-2019 | 06-05-2019 | Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 20-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 43023 1 | Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit | Sun Pharmaceutical Industries, Inc. / 17,136 20-count units | Class II | Terminated |
| D-1389-2019 | 06-05-2019 | Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Release Tablets, USP, Allergy & Congestion, 30-count box. Distributed by: Walgreen Co. 200 Wilmore Rd. Deerfield, IL 40015. Made in India. UPC 3 11917 19454 7 | Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit | Sun Pharmaceutical Industries, Inc. / 14,399 30-count units | Class II | Terminated |
| D-1387-2019 | 06-05-2019 | Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 30-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 39131 0 | Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit | Sun Pharmaceutical Industries, Inc. / 9528 30 count units | Class II | Terminated |
| D-1408-2019 | 06-05-2019 | Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. Bottle, Distributed by C.D.M.A. Inc., Novi, MI 48376, Quality Choice, NDC 63868-430-04, UPC 635515992474. | cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | P & L Developments, LLC / 17,664 bottles | Class II | Terminated |
| D-1407-2019 | 06-05-2019 | Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Gluten Free, Grape Flavor, 5 mg/5mL, 4 FL. oz. Bottle, Distributed by Dolgencorp, LLC, 100 mission ridge, Goodlettsville, TN 37072, NDC 55910-878-04, UPC 359726178051. | cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | P & L Developments, LLC / 202,068 bottles | Class II | Terminated |
| D-1340-2019 | 06-03-2019 | Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513 India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430 USA, NDC 68462-711-71 Package NDCs: 68462-711-71; 68462-711-88 | Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly. | Glenmark Pharmaceuticals Inc., USA / 31,656 boxes | Class II | Terminated |
| D-1522-2019 | 05-31-2019 | Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (473 ml), Dist. BY: Gericare Pharmaceuticals corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-403-16 | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC / 6165 bottles | Class II | Terminated |
| D-1527-2019 | 05-31-2019 | Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 FL. Oz. (1 PT.) 473 mL, Manufactured by RIJ Pharmaceutical Corp. 40 Commercial Avenue Middletown, NY 10941, Distributed by Kinray Inc. Whitestone, NY 11357, NDC 53807-216-16 | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC / 15435 bottles | Class II | Terminated |
| D-1525-2019 | 05-31-2019 | Ritussin DM Double Strength, 4 FL. OZ. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941 | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC / 7653 bottles | Class II | Terminated |
| D-1524-2019 | 05-31-2019 | Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 52807-177-16 | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC / 3864 bottles | Class II | Terminated |
| D-1523-2019 | 05-31-2019 | Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16 | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC / 3789 bottles | Class II | Terminated |
| D-1520-2019 | 05-31-2019 | Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-204-04 | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC / 8645 bottles | Class II | Terminated |
| D-1341-2019 | 05-31-2019 | ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-902-12. | Failed Dissolution Specifications: Out of specification result for dissolution. | Chiesi USA, Inc. / 2118 bottles | Class II | Terminated |
| D-1526-2019 | 05-31-2019 | Gericare Geri-Tussin DM, 16 FL OZ (473 mL), Geri-care Phamaceuticals Corp. 1650 63rd Street Brooklyn, NY, NDC 57896-660-16 | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC / 6213 bottles | Class II | Terminated |
| D-1342-2019 | 05-31-2019 | Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32. | Failed Dissolution Specifications: Out of specification result for dissolution. | Chiesi USA, Inc. / 2598 bottles | Class II | Terminated |
| D-1521-2019 | 05-31-2019 | Ritussin DM Children & Adults, 4 Fl. Oz. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-409-04 | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC / 5107 bottles | Class II | Terminated |
| D-0610-2020 | 05-30-2019 | Memorial Central TPN. Rx Only, Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Serv., 3908 TENN.AVE., SUITE F., CHATTANOOGA, TN., 37409, | Lack of sterility assurance. | Surgery Pharmacy Services Inc / 1149 bags | Class II | Terminated |
| D-0611-2020 | 05-30-2019 | Trisodium Citrate 0.5% CRRT SOLUTION. RX Only. Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Services,3908 TENN.AVE. CHATT,TN37409 | Lack of sterility assurance. | Surgery Pharmacy Services Inc / 84 bags | Class II | Terminated |
| D-1400-2019 | 05-28-2019 | Sn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc. | Lack of Processing Controls. | Synthetopes Inc / 3 vials | Class II | Terminated |
| D-1402-2019 | 05-28-2019 | Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc. | Lack of Processing Controls. | Synthetopes Inc / 20 vials | Class II | Terminated |
| D-1406-2019 | 05-28-2019 | Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc. | Lack of Processing Controls. | Synthetopes Inc / 45 vials | Class II | Terminated |
| D-1401-2019 | 05-28-2019 | Sn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc. | Lack of Processing Controls. | Synthetopes Inc / 35 vials | Class II | Terminated |
| D-1404-2019 | 05-28-2019 | Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc. | Lack of Processing Controls. | Synthetopes Inc / 82 vials | Class II | Terminated |
| D-1405-2019 | 05-28-2019 | Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc. | Lack of Processing Controls. | Synthetopes Inc / Unknown | Class II | Terminated |
| D-1403-2019 | 05-28-2019 | Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C, Synthetopes, Inc. | Lack of Processing Controls. | Synthetopes Inc / 68 vials | Class II | Terminated |
| D-1399-2019 | 05-28-2019 | Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc. | Lack of Processing Controls. | Synthetopes Inc / 20 vials | Class II | Terminated |
| D-1395-2019 | 05-28-2019 | Pecgen DMX Cough Suppressant Expectorant, Contains the same active ingredients as Trispec DMX, Sugar Free, Alcohol Free, Dye Free, Gluten Free, Cherry Raspberry Flavor, 16 Fl. oz. (474 mL), Manufactured in the USA for Kramer Novis, San Juan, PR 00917, www.kramernovis.com, NDC 52083-630-16. Package NDCs: 52083-630-16 | Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician. The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age. | Novis PR, Inc. / 5766 bottles | Class I | Terminated |
| D-1320-2019 | 05-23-2019 | Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 20201, Manufactured by: Lupin Limited, Mandideep 462 046 India. NDC 68180-723-20 Package NDCs: 68180-722-20; 68180-722-10; 68180-722-04; 68180-722-05; 68180-723-20; 68180-723-10; 68180-723-04; 68180-723-05 | Complaint received of metal piece identified in the product bottle prior to the reconstitution. | Lupin Pharmaceuticals Inc. / 18,408, 60 mL bottles | Class II | Terminated |
| D-1322-2019 | 05-23-2019 | Bacteriostatic Water for Injection, 10 mL vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 716 vials | Class II | Terminated |
| D-1326-2019 | 05-23-2019 | Human Chorionic Gonadotropin 12,000 IU vials Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 104 vials | Class II | Terminated |
| D-1324-2019 | 05-23-2019 | Human Chorionic Gonadotropin 10,000 IU vials, Rx only Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 26 vails | Class II | Terminated |
| D-1329-2019 | 05-23-2019 | Nandrolone Decanoate 200 mg/mL Injectable, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 50 vials | Class II | Terminated |
| D-1330-2019 | 05-23-2019 | Sermorelin/Ipamorelin 18 mg/15 mg, 10mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 24 vials | Class II | Terminated |
| D-1335-2019 | 05-23-2019 | Sermorelin/GHRP-2 &6 (9-9-9 mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 25 vials | Class II | Terminated |
| D-1323-2019 | 05-23-2019 | B-complex (Thiamine 100mg, Riboflavin 2mg, Niacinamide 100 mg, Pyridoxine 2mg, Depanthenol 5mg) injectable, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1611-30 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 4 vials | Class II | Terminated |
| D-1333-2019 | 05-23-2019 | Sermorelin/GHRP-2 & 6 (3-3-3 MG) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 100 vials | Class II | Terminated |
| D-1338-2019 | 05-23-2019 | Testosterone Cypionate 200 mg/mL, in a) 5mL vials and b)10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1702-10 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / a) 114 vials and b) 566 vials | Class II | Terminated |
| D-1325-2019 | 05-23-2019 | Human Chorionic Gonadotropin 5,000 IU vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 279 vials | Class II | Terminated |
| D-1339-2019 | 05-23-2019 | Trimix 30mg/1 mg/10mcg/mL ( 30 mg Papaverine, 1mg phentolamine mesylate, 30 mcg alprostadil) Injectable, 5mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 4 vials | Class II | Terminated |
| D-1336-2019 | 05-23-2019 | Testosterone 200 mg/mL, 30 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1702-30 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 704 vials | Class II | Terminated |
| D-1334-2019 | 05-23-2019 | Sermorelin/GHRP-2 &6 (9-9-9-mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 1 vial | Class II | Terminated |
| D-1331-2019 | 05-23-2019 | Sermorelin/GHRP-2 9 mg/9 mg vials Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 6 vials | Class II | Terminated |
| D-1327-2019 | 05-23-2019 | Ipamorelin Acetate 9 mg/9mL Injectable vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 11 vials | Class II | Terminated |
| D-1332-2019 | 05-23-2019 | Sermorelin/GHRP-2 9 mg/6 mg vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 66 vials | Class II | Terminated |
| D-1328-2019 | 05-23-2019 | Lipo MIC-12 (Methylcobalamin, USP 1mg, Methionine USP 15mg, Inositol, FCC 50mg, Choline Chloride, FCC 100 mg) 10 mL Injectable vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 669 vials | Class II | Terminated |
| D-1337-2019 | 05-23-2019 | Testosterone Cyp/Pro 95/5%, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 371 vials | Class II | Terminated |
| D-1386-2019 | 05-22-2019 | Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20 Package NDCs: 63323-373-00; 63323-373-02; 63323-374-20 | Failed Impurities/Degradation Specifications. | Fresenius Kabi USA, LLC / 11,981 units | Class III | Terminated |
| D-1360-2019 | 05-21-2019 | Hyoscyamine Sulfate Elixir 0.125 mg per 5 mL, Rx Only, 473 mL (16 oz.) bottle, NDC:39328-048-16, Patrin Pharma, Skokie IL 60076. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 24,384 bottles | Class II | Terminated |
| D-1378-2019 | 05-21-2019 | Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 Rectal Suppositories per carton, NDC: 0536-1389-12, Distributed by Rugby Laboratories, Livonia MI 48152 USA. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 82,872 bottles | Class II | Terminated |
| D-1356-2019 | 05-21-2019 | Pedia Relief Cough-Cold Oral Solution, Alcohol free, antihistamine, cough suppressant, nasal decongestant, Chlorpheniramine Maleate, USP 2 mg; Dextromethorphan HBr, USP 10 mg; Pseudoephedrine HCl, USP 30 mg in each 2 tsp (10 mL)), 4 Fl. oz. (118 mL) bottle, NDC:0904-5050-20, Distributed by Major Pharmaceuticals, Livonia MI 48152. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 17,748 bottles | Class II | Terminated |
| D-1370-2019 | 05-21-2019 | Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0770-97, b) One Pint (473 mL) bottle., NDC: 0536-0770-85, Distributed by Rugby Laboratories, Livonia, MI 48152. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 438,624 bottles | Class II | Terminated |
| D-1361-2019 | 05-21-2019 | Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 361,260 bottles | Class II | Terminated |
| D-1377-2019 | 05-21-2019 | Laxative Suppositories (Bisacodyl USP, 10 mg), a) 12 Suppositories per carton, NDC: 0536-1355-12, b) 100 Suppositories per carton, NDC: 0536-1355-01, Distributed Rugby Laboratories, Livonia, MI 48152. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 120,204 cartons | Class II | Terminated |
| D-1379-2019 | 05-21-2019 | Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 suppositories per carton, NDC: 0904-7688-22, Distributed by Major Pharmaceuticals, Livonia MI 48152. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 177,408 bottles | Class II | Terminated |
| D-1367-2019 | 05-21-2019 | Kid Kare Childrens Cough/Cold Liquid, Antihistamine, Cough Suppressant, Nasal Decongestant, Cherry Flavored, Alcohol Free, (Chlorpheniramine Maleate, USP 2 mg, Dextromethorphan HBr, USP 10 mg, Pseudoephedrine HCl, USP 30 mg in each 2 tsp (10mL)), 4 Fl. oz. bottle, NDC: 0536-2310-97, Distributed by Rugby Laboratories, Livonia MI 48152. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 66,060 bottles | Class II | Terminated |
| D-1369-2019 | 05-21-2019 | Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/10 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0970-97, b) One Pint (473 mL) bottle, 0536-0970-85, Distributed by Rugby Laboratories, Livonia, MI 48152. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 176,580 bottles | Class II | Terminated |
| D-1368-2019 | 05-21-2019 | Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic Expectorant, One Pint (473 mL) oz. bottle, NDC: 0536-0825-85, Distributed by Rugby Laboratories, Livonia, MI 48152. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 249,744 bottles | Class II | Terminated |
| D-1345-2019 | 05-21-2019 | RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 13668-589-06, Manufactured by Bio-Pharm Inc., Levittown PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 48,955 bottles | Class II | Terminated |
| D-1385-2019 | 05-21-2019 | Bisacodyl Suppositories, Brite Stock, Reese. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / N/A | Class II | Terminated |
| D-1373-2019 | 05-21-2019 | Lactulose Solution, USP 10 g/15 mL, For Oral or Rectal Administration, Rx Only, 16 FL. oz. Bottle, NDC:13668-574-10, Manufactured By Bio-Pharm, Levittown, PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 153.540 bottles | Class II | Terminated |
| D-1362-2019 | 05-21-2019 | Acetic Acid Otic Solution, USP, 2%, Rx Only, 15 mL bottle, NDC: 64980-424-15, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Distributed by Rising Pharmaceuticals Ins Saddie Brook, NJ 07663. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 14,016 bottles | Class II | Terminated |
| D-1364-2019 | 05-21-2019 | Guaifenesin DAC Oral Solution, Sugar free, (Guaifenesin, Pseudoephedrine HCl and Codeine Phosphate Oral Solution, USP), Expectorant, Nasal Decongestant, Cough Suppressant, 100 mg/30 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 16571-301-16, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Distributed by Rising Pharmaceuticals Inc., Allendale, NJ 07401. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 6,000 bottles | Class II | Terminated |
| D-1348-2019 | 05-21-2019 | Children's Mapap Acetaminophen Liquid, Fever reducer, Pain reliever, Alcohol free, Aspirin free, Cherry flavored, acetaminophen 160 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle, NDC 0904-1985-20, b) One Pint (473 mL) bottle, NDC: 0904-1985-16, Distributed by Major Pharmaceuticals, Livonia MI 48152. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 2,646,228 bottles | Class II | Terminated |
| D-1376-2019 | 05-21-2019 | Hydrocortisone Acetate Suppositories, 25 mg, Rx Only, For rectal administration, a) 12 Adult Suppositories per carton, NDC: 59741-301-12, b) 24 Adult Suppositories per carton, NDC: 59741-301-24, Manufactured by Bio-Pharm Inc., Levittown PA 19057. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 140,436 suppositories | Class II | Terminated |
| D-1350-2019 | 05-21-2019 | Robafen AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC:0904-6479-16, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 131,328 bottles | Class II | Terminated |
| D-1363-2019 | 05-21-2019 | Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 16571-302-16, Distributed by Rising Pharmaceuticals Inc., Saddle Brook, NJ 07663 | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 233,388 bottles | Class II | Terminated |
| D-1355-2019 | 05-21-2019 | Robafen DM Cough Sugar-Free Clear Cough Expectorant (Dextromethorphan HBr, USP 20 mg), Expectorant (Guaifenesin, USP 200 mg in each 2 teaspoonfuls (10mL)), 4 Fl. oz. (118 mL) bottle, NDC: 0904-6306-20, Distributed by Major Pharmaceuticals, Livonia MI 48152. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 262,008 bottles | Class II | Terminated |
| D-1366-2019 | 05-21-2019 | Pain & Fever Oral Solution (Acetaminophen 160 mg/5 mL), Sugar free, Aspirin & Alcohol free, Cherry flavored, a) 4 Fl. oz. bottle, NDC: 0536-0122-97, b) One Pint (473 mL) bottle, NDC: 0536-0122-85, Distributed by Rugby Laboratories, Lavonia, MI 48152 USA. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 1,883,796 bottles | Class II | Terminated |
| D-1346-2019 | 05-21-2019 | Children's Acetaminophen Liquid, 160 mg per 5 mL, Fever and Pain, Alcohol free, aspirin free, ibuprofen free, Cherry Flavor, 4 FL. oz. (118 mL) bottle, NDC: 59741-101-06, Manufactured by Bio-Pharm, Inc., Levittown PA 19057, Assured. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 58,272 bottles | Class II | Terminated |
| D-1380-2019 | 05-21-2019 | Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, For Oral Use Only, Rx Only, 120 mL bottle, NDC 23155-292-51, Mfd for Heritage Pharmaceuticals Inc., Eatontown, NJ 07724. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 1,126,404 bottles | Class II | Terminated |
| D-1374-2019 | 05-21-2019 | Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551-12, Patrin Pharma | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 5,681 bottles | Class II | Terminated |
| D-1382-2019 | 05-21-2019 | RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 23155-317-51, Mfd for Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 52,368 bottles | Class II | Terminated |
| D-1375-2019 | 05-21-2019 | Memantine Hydrochloride Oral Solution, 2 mg/mL, Rx Only, 12 FL. oz.. bottle, NDC: 13668-573-09, Manufactured By Bio-Pharm Inc., Levittown, PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 264 bottles | Class II | Terminated |
